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Daratumumab combined with teclistamab or talquetamab for frail adults with newly diagnosed multiple myeloma

EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial

Phase 2 Interventional European Myeloma Network B.V. · NCT07107529

This study will test whether adding teclistamab or talquetamab to daratumumab helps frail adults newly diagnosed with multiple myeloma remain progression-free at 18 months.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Myeloma Network B.V. Research network
Drugs / interventionschemotherapy, radiation, daratumumab, teclistamab, talquetamab
Locations29 sites (Ascoli Piceno and 28 other locations)
Trial IDNCT07107529 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label phase II study with two parallel cohorts enrolling frail, treatment-naïve adults with measurable newly diagnosed multiple myeloma. One cohort receives teclistamab plus daratumumab and the other receives talquetamab plus daratumumab for a fixed initial treatment period. After a treatment-free interval, patients with confirmed disease progression may be re-treated with the same assigned combination. The primary outcome is progression-free survival at 18 months, with follow-up during a post-treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with newly diagnosed, measurable multiple myeloma who are treatment-naïve and classified as frail by the Simplified IMWG frailty index and meet laboratory and contraceptive requirements.

Not a fit: Patients with non-secretory myeloma, disease measurable only by urine or plasmacytoma, or who do not meet the study's safety and laboratory criteria may not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, combining daratumumab with teclistamab or talquetamab could extend progression-free survival and provide a tolerable frontline option tailored to frail patients.

How similar studies have performed: Bispecific antibodies such as teclistamab and talquetamab have shown strong responses in relapsed/refractory multiple myeloma, but combining them with daratumumab as frontline therapy for frail newly diagnosed patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study
2. Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
3. Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL \[≥100 mg/L\] and abnormal serum immunoglobulin kappa/lambda FLC ratio
4. Frail according to the Simplified IMWG frailty index
5. Have clinical laboratory values meeting defined range
6. Patients of childbearing potential must agree to use adequate/highly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug

Exclusion Criteria:

1. Non-secretory MM or measurable disease by urine or plasmacytoma only
2. Central nervous system involvement of myeloma
3. Significant pulmonary dysfunction
4. Stroke, transient ischemic attack, or seizure within 6 months of eligibility
5. Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
6. HIV and Hepatitis infections
7. Exclude for any of the following:

   1. Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.
   2. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
8. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility
9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)
10. Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility
11. Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to \>40 mg dexamethasone within the 14 days prior to C1D1
12. Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed
13. Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing
14. Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery
15. Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device \<4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected
16. Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study
17. Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Where this trial is running

Ascoli Piceno and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaNewly diagnosed multiple myelomaFrail patientTalquetamabTeclistamab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.